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Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension

ConditionsTourniquet HypertensionIntraoperative HypertensionTotal Ankle ArthroplastyAnkle Fusion
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDuke University

About this trial

The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

ASA 4 or 5

Diagnosis of chronic pain

Daily chronic opioid use (over 3 months of continuous opioid use).

Inability to communicate pain scores or need for analgesia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mepivacaine

    Drug

    An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.

  • Saline

    Drug

    An infiltration of saline superomedially to the femoral artery via perineural catheter.

  • Perifemoral Injection of Local Anesthetic

    Procedure/Surgery

    Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.

  • Perifemoral Injection of Local Anesthetic

    Procedure/Surgery

    Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Mepivacaine Block GroupExperimental treatment 2 interventions
Group B: Saline Sham GroupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in tourniquet hypertension as measured by systolic blood pressure

Infiltrating study drug to reverse intraoperative tourniquet hypertension

Time frame
From time of injection to 30 minutes after injection

Secondary outcomes

1

Pain Scores (NRS11)

The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

Time frame
Perioperative start until 2 hours after admission to PACU
2

Opioid consumption

Perioperative opioid consumption as measured in oral morphine equivalents (OMEs)

Time frame
Perioperative start until 2 hours after admission to PACU
3

Quadriceps motor function

Gross quadriceps motor function as measured by leg extension

Time frame
1 hour after extubation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov
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